Core Insights - Berry Genomics (000710.SZ) announced that its subsidiary, Hangzhou Berry Health and Technology Co., Ltd., has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its third-generation sequencing instrument, Sequel II CNDx, marking it as the first clinically approved third-generation sequencing platform globally [1][2] Group 1: Product Approval and Features - The Sequel II CNDx is the first third-generation sequencing platform approved for clinical use, enabling rapid implementation of third-generation sequencing solutions in local laboratories [1] - The approval allows for "one machine, multiple uses" and "mixed loading," which reduces sample waiting times, accelerates report cycles, and enhances service quality within hospitals [1] Group 2: Clinical Applications and Impact - The clinical approval of Sequel II CNDx will enhance the birth defect prevention system and significantly improve the detection capabilities for complex single-gene diseases [2] - Berry Genomics aims to deepen the clinical application of third-generation sequencing technology by optimizing AI algorithms and local deployment plans, making testing services more precise, efficient, and economical for families [2] - The large-scale application of third-generation sequencing technology is expected to accelerate major public health initiatives, such as the prevention of birth defects, both in China and globally [2]

Group 1 - Berry Genomics' subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has received the NMPA medical device registration certificate for its third-generation sequencing instrument, Sequel® II CNDx, making it the first clinically approved third-generation sequencing platform globally [1] - The approval of Sequel® II CNDx enables rapid implementation of third-generation sequencing solutions in local clinical laboratories, reducing sample waiting times, accelerating report cycles, and enhancing service quality within hospitals [1] - Berry Genomics has achieved full self-production of third-generation sequencing testing reagents and the local deployment of an intelligent report interpretation system, providing comprehensive localized services from sample collection to report management [1] Group 2 - The clinical approval of Sequel® II CNDx enhances the birth defect prevention system and significantly improves the detection capabilities for complex single-gene diseases [2] - Berry Genomics aims to deepen the clinical application of third-generation sequencing technology by optimizing AI algorithms and local deployment plans, making testing services more precise, efficient, and economical for families [2] - The large-scale application of third-generation sequencing technology is expected to accelerate the advancement of major public health projects, such as birth defect prevention, both in China and globally [2]

Group 1 - The core point of the article is that Berry Genomics' subsidiary has received regulatory approval for its third-generation gene sequencer, Sequel II CNDx, marking it as the first clinically approved platform of its kind globally [1][2] - The approval allows for the rapid implementation of third-generation sequencing solutions in local clinical laboratories, enhancing service quality and reducing sample wait times [1] - Berry Genomics has achieved full local production of third-generation sequencing reagents and the deployment of an intelligent report interpretation system, providing comprehensive localized services from sample collection to report management [1] Group 2 - The clinical approval of Sequel II CNDx will improve the birth defect prevention system and enhance the detection capabilities for complex single-gene diseases [2] - The company aims to further develop the clinical applications of third-generation sequencing technology by optimizing AI algorithms and local deployment plans, making testing services more accessible and cost-effective for families [2] - The large-scale application of third-generation sequencing technology is expected to significantly advance major public health initiatives, such as the prevention of birth defects, both in China and globally [2]

Core Insights - Berry Genomics' subsidiary, Hangzhou Berry Genomics, has received NMPA approval for its Sequel® II CNDx third-generation gene sequencer, marking it as the first clinically approved third-generation sequencing platform globally [1][2] - The approval allows for rapid implementation of third-generation sequencing solutions in local clinical laboratories, enhancing service quality and reducing sample wait times [1] - Berry Genomics has achieved full local production of third-generation sequencing reagents and the deployment of an intelligent report interpretation system, providing comprehensive localized services from sample collection to report management [1] Industry Impact - The clinical approval of Sequel® II CNDx will enhance the birth defect prevention system and significantly improve the detection capabilities for complex single-gene diseases [2] - The advancement of domestic technology is expected to accelerate its global reach, with Berry Genomics aiming to optimize AI algorithms and local deployment plans to lower technical barriers [2] - The large-scale application of third-generation sequencing technology is anticipated to promote significant public health initiatives, particularly in the prevention of birth defects both in China and globally [2]

Core Viewpoint - Berry Genomics (000710) announced that its wholly-owned subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has recently received the medical device registration certificate from the National Medical Products Administration (NMPA) for its third-generation gene sequencer, Sequel II CNDx [1] Group 1 - The Sequel II CNDx is a third-generation gene sequencer [1] - The medical device registration certificate was issued by the National Medical Products Administration (NMPA) [1]

Core Viewpoint - Berry Genomics (000710.SZ) has announced that its subsidiary, Hangzhou Berry Health and Technology Co., Ltd., has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its third-generation sequencing instrument, Sequel?IICNDx, marking it as the first third-generation sequencing platform approved for clinical use globally [1] Group 1 - The Sequel?IICNDx instrument enables rapid implementation of third-generation sequencing solutions in local clinical laboratories, facilitating "multi-use" and "mixed operation" capabilities [1] - The approval of the Sequel?IICNDx is expected to reduce sample waiting times, accelerate report cycles, and enhance the quality and level of in-hospital services [1] - Berry Genomics has achieved full self-production of third-generation sequencing detection reagents and local deployment of an intelligent report interpretation system [1] Group 2 - The company provides comprehensive localized construction services for clinical processes, including sample collection and extraction, library construction, high-throughput sequencing, data analysis and interpretation, and report management [1]

证券代码：000710 证券简称：贝瑞基因 公告编号：2025-060 成都市贝瑞和康基因技术股份有限公司 关于全资子公司三代基因测序仪Sequel®IICNDx 获得医疗器械注册证的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有 虚假记载、误导性陈述或重大遗漏。 三代基因测序仪Sequel® II CNDx ，是全球首款获准应用于临床的三代基因 测序平台，该测序仪的获批使三代测序解决方案可快速落地临床机构本地实验室， 能真正实现"一机多用""混合上机"，进而减少样本等待时间、加速报告周期、 提升院内服务质量与水平。截至目前，贝瑞基因已完全实现三代测序配套检测试 剂的自主生产和智能化解读报告系统的本地部署交付，可进一步为临床提供从样 本采集及提取、文库构建、高通量测序、数据分析解读到报告管理的全流程本地 化建设服务。 Sequel® II CNDx临床获批后，不仅助力临床进一步完善出生缺陷防控体系、 显著提升复杂单基因病检测能力，更推动国产技术成果加速迈向全球。贝瑞基因 将持续深化三代测序技术的临床应用，通过优化AI算法与完善本地化部署方案， 进一步降低技术门槛，让更多家庭享受到更精准、 ...

Core Viewpoint - Berry Genomics (000710.SZ) has announced that its wholly-owned subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its third-generation sequencing instrument, Sequel?IICNDx, marking it as the world's first clinically approved third-generation sequencing platform [1] Group 1 - The Sequel?IICNDx instrument enables rapid implementation of third-generation sequencing solutions in local clinical laboratories, facilitating "multi-use" and "mixed operation" capabilities [1] - The approval of the Sequel?IICNDx is expected to reduce sample waiting times, accelerate report cycles, and enhance the quality and level of in-hospital services [1] - Berry Genomics has achieved full self-production of third-generation sequencing detection reagents and local deployment of an intelligent report interpretation system [1] Group 2 - The company provides comprehensive localized construction services for clinical processes, including sample collection and extraction, library construction, high-throughput sequencing, data analysis and interpretation, and report management [1]

Core Viewpoint - Berry Genomics has announced that its subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has received a medical device registration certificate from the National Medical Products Administration for its third-generation gene sequencer, Sequel II CNDx, marking it as the world's first third-generation gene sequencing platform approved for clinical use [1] Company Summary - The Sequel II CNDx is the first third-generation gene sequencing platform to be approved for clinical application globally [1] - Berry Genomics has achieved full self-production of third-generation sequencing detection reagents and has deployed an intelligent report interpretation system locally [1]

Core Viewpoint - Berry Genomics announced that its wholly-owned subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has received a medical device registration certificate from the National Medical Products Administration for its third-generation sequencer, Sequel® II CNDx, making it the first third-generation sequencing platform approved for clinical use globally [1] Group 1 - The Sequel® II CNDx is the world's first third-generation sequencing platform approved for clinical application [1] - Berry Genomics has achieved full self-production of third-generation sequencing detection reagents and the local deployment of an intelligent report interpretation system [1]